Comparison Between an Electronic Mobile Device and Optical Coherence Tomography to Determine Cup-to-disc Ratio

NCT02988752 | Unknown

• 1 other identifier: COZ001
• Study Type: interventional
• Target: 110
• Locations: 1 country
• Sites: 1

Brief Summary

This study was a non-inferiority trial with masked data analysis. Individuals ranging from 18 to 60 years from both genders that met the pre-defined criteria were included. This study was carried out in Recife at Clinica Oftalmologica Zona Sul and at Centro de Informatica-UFPE. Using both equipment, 5 vertical cup-to-disc ratio (VCDR) evaluations were performed for each eye of the individuals, under midriatic conditions. Evaluations were done by examiners who did not know previously results obtained from other equipment. Data was collected by the main researcher of this research. This study was approved by the ethics committee before it started and all research members signed the TCLE agreement. The statistical test employed in this study was Pearson Correlation test.

Conditions

Glaucoma

Outcome Measures

Primary Outcomes (1)

• Objective C/D Ratio measure

  To measure vertical cup to disc ratio in an objective way

  One Year

Study Arms (2)

Electronic Mobile Device

EXPERIMENTAL

Use an Electronic Low Cost Mobile Device To Determine C/D Ratio And Compare Results With Gold Standard Optical Coherence Tomography Results. The equipment needs mydriatic conditions and does not touch the patient's eye. The equipment uses a panoptik and a camera to access eye fundus.

Device: Electronic Mobile Device

Optical Coherence Tomography

ACTIVE COMPARATOR

Device considered as gold standard to determine c/d ratio. Needs mydriatic conditions.

Device: Optical Coherence Tomography

Interventions

Electronic Mobile Device DEVICE

Measure C/D Ratio With An Equipment Attached To A Ophthalmoscope That Will Determine C/D Ratio Without Touching Patient's Eyes. To Perform It We Need Mydriatic Conditions.

Electronic Mobile Device

Optical Coherence Tomography DEVICE

Measure C/D Ratio With OCT, Considered Gold Standard Equipment

Also known as: OCT

Optical Coherence Tomography

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may not qualify if:

• Cancer
• Cataract
• Eyes transparency loss
• Best Av \< 0.4
• Eye surgery in the last 12 Months
• Use of drugs that leads to any kind of Neuropathy

Sponsors & Collaborators

• Clinica Oftamologica Zona Sul: lead

Study Sites (1)

Clinica Oftalmologica Zona Sul

Recife, Pernambuco, 51110000, Brazil

Location

MeSH Terms

Conditions

Glaucoma

Interventions

Tomography, Optical Coherence

Condition Hierarchy (Ancestors)

Ocular Hypertension; Eye Diseases

Intervention Hierarchy (Ancestors)

Tomography, Optical; Optical Imaging; Diagnostic Imaging; Diagnostic Techniques and Procedures; Diagnosis; Tomography; Investigative Techniques

Study Officials

• ANDREA SARMENTO

  COZ

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD

Study Record Dates

• First Submitted: June 2, 2016
• First Posted: December 9, 2016
• Study Start: October 1, 2016
• Primary Completion: November 1, 2016
• Study Completion: November 1, 2017
• Last Updated: December 9, 2016

Record last verified: 2016-12

Data Sharing

• IPD Sharing: Will not share

Locations

BR (1)